Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Master Formula Record (MFR) is a master document for any
pharmaceutical product. MFR contains all information about the manufacturing process
for the product. MFR is prepared by the research and development team of the
company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
CHANGE CONTROL,BENEFITS OF CHANGE CONTROL SYSTEM,MANAGEMENT OF CHANGE AND CONTINUOUS IMPROVEMENT(Prepare a Change Proposal,Classify & Approve Proposed Changes,Develop an Implementation Plan, Install the Change,Verify Installation,Close out the change
) FLOW CHART OF CHANGE MANAGEMENT,HANDLING AND CONTROLLING CHANGES,SOP ON CHANGE CONTROL SYSTEM,
CATEGORY OF CHANGES(Major Changes,Moderate changes,Minor changes),ENSURING TRAINING & PROCEDURES IN A MANAGEMENT OF CHANGE PROGRAM,LEVEL OF APPROVAL,REGULATOR PROSPECTIVE OF CHANGE CONTROL(21 CFR Part 211: Sec. 211.100,21 CFR Part 211.194 (Laboratory Records),ICH Q7A,USFDA Guidance for Industry: Change to an approved NDA or ANDA ( April 2004- Revison-1)),CONCLUSION
,
validation is an important documentation protocol used in most of the laboratories and industries which is used for validation and evaluating different research protocols and equipment used in product formulation and development
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MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. VALIDATION OF PHARMACEUTICAL
PROCESSES
Presented By..
Mr. Rahul S. Dalvi
M. Pharm. (SEM – I)
Dept. of Pharmaceutics
Guided By..
Dr. A. J. Shinde
Asso. Professor of
Pharmaceutics
BHARATI VIDYAPEETH
COLLEGE OF PHARMACY, KOLHAPUR
2015-2016
1
Date: 02/12/2015
2. Contents :
Introduction
Need of Validation
Scope of Validation
Documentation of Validation
Validation Master Plan
Types of Validation
Process Validation
Cleaning Validation
Equipment Validation
Validation of Analytical method
Conclusion
References
2
3. Introduction
The concept of validation was first proposed by Food and Drug
Administration(FDA) officials, Ted Byers and Bud Loftus, in the
mid 1970s in order to improve the quality of pharmaceuticals.
Validation is "Establishing documented evidence that provides a
high degree of assurance that a specific process will consistently
produce a product meeting its pre-determined specifications and
quality attributes.
This is to maintain and assure a higher degree of quality of food
and drug products.
3
4. Need for validation
Customer satisfaction
Customer mandated
Product liability
Control production cost
The development of the next generation
Safety
4
5. Scope of validation
Analytical Test Methods
Instrument Calibrations
Process Utility Services
Raw Material
Equipment
Facilities
Product Design
Cleaning
Operators
5
6. Documentation of Validation
The validation activity cannot be completed without proper
documentation of each and every minute activity with utmost details.
Documentation of validation is generally different types such as:
Validation Master Plan(VMP)
Validation Protocol(VP)
Validation Reports(VR)
Standard Operating Procedure(SOP)
6
7. Advantages :
It gives idea about future performed:
What activities are to be performed?
Who is going to perform these activities?
When the activities should start and when
they should get over?
What documents will be generated?
What the policy on revalidation?
Validation master plan
7
8. V.M.P. includes..
Premises
Processes
Products
Format for protocol and other documentation
List of relevant SOPs
Planning and scheduling
Location
Estimation of staffing requirements
A time plan of the project
8
9. Guidelines on Preparing V.M.P.
V.M.P. write on A4 size paper.
File in a presentable form.
Have sufficient explanatory drawings.
Clearly divide the V.M.P. in different form.
It must be dated and signed properly by authorized
persons.
If found any step inappropriate is discuss this the
F.D.A. people in advance.
9
10. Types of Validation
The major types of Validation :
Process validation
Cleaning validation
Equipment validation
Validation of analytical methods
10
11. Process validation
Definition
As per FDA Nov.2008,‘The collection of data from the process
design stage throughout production,which establishes scientific
evidence that a process is capable of consistently delivering quality
products.
11
12. Process validation life cycle:
Stage 1. Process design
Stage 2. Process qualification
Stage 3. Continued process
verification
12
13. Types of Process validation:
Prospective validation.
Retrospective validation.
Concurrent validation.
Revalidation.
13
15. Cleaning validation :
Definition: “A process of attaining and documenting sufficient
evidence to give reasonable assurance, given the current state of Science
and Technology, that the cleaning process under consideration does, and
/ or will do, what it purpoes to do.”
Objective..
To minimize cross contamination.
To determine efficiency of cleaning process.
To do troubleshooting in case problem identified in the
cleaning process and give suggestions to improve the process.
15
16. Source of contamination:
Cross contamination product of one product into another.
Product contamination by a foreign material.
Microbial contamination.
Cleaning methods:
Manual cleaning method.
Semi automated procedures.
Fully automated procedures.
16
19. Equipment Validation
Definition
As per FDA, May 1987,‘Action of proving that any equipment
works correctly and leads to the expected result is equipment
qualification.
It is not a single step activity but instead result from many
discrete activities.
19
22. Validation of analytical methods
22
Definition : “The process by, which it is established, by laboratory studies, that
the performance characteristics of the method meet the requirements for the
intended analytical application”.
Accuracy :
“The closeness of test results obtained by that method to the true value. This
accuracy should be established across its range.”
Precision:
“The degree of agreement among individual test results when the method is
applied repeatedly to multiple sampling of a homogenous sample.”
23. 23
Specificity :
“The ability to assess unequivocally the analyte in the presence of
components that may be expected to be present, such as impurities
degradation products and matrix components.”
Limit of Quantitation :
“A characteristic of quantitative assays for low levels of compounds in
sample matrices such as impurities in bulk substances and degradation
products in finished pharmaceuticals. It is the lowest amount of analyte in
a sample that can be determined with acceptable precision and accuracy
under the stated experimental conditions.”
24. 24
Range :
“Interval between the upper and lower of analyte (including these levels) that
have been demonstrated to be determined with a suitable level of precision ,
accuracy and linearity using the method as written. The range is normally
expressed in the same units as test results. ( e.g. Percentage , parts per
million, etc.) obtained by the analytical method.”
Ruggedness:
The degree of reproducibility of test results obtained by the analysis of the
same sample under a variety of conditions such as different laboratories,
different analysts, different instruments , different lots of reagents, different
elapsed assay times, different assay temperatures, different days, etc.”
25. 25
Robustness:
"A measure of its capacity to remain unaffected by small but deliberate
variations in method parameters and provides an indication of its reliability
during normal usage.”
Linearity :
“Its ability to elicit tests that are directly or by a well defined mathematical
transformations proportional to the concentration of analyte in samples
within a given range.”
Limit of Detection :
The lowest amount of analyte in a sample that can be detected but not
necessarily quantitated, under the stated experimental conditions.”
26. Conclusion
Validation has been proven assurance for the process efficiency and
sturdiness and it is the full fledged quality attributing tool for the
pharmaceutical industries.
Validation is the commonest word in the areas of drug development,
manufacturing and specification of finished products. It also renders
reduction in the cost linked with process monitoring, sampling and
testing.
Apart from all the consistency and reliability of a validated process
to produce a quality product is the very important for an industry.
26
27. References
1. Fundamental of quality assurance techniques..by Ramesh Sawant and
Sandip Hapse,First edition Dec 2011, Career publications.
2. Pharmaceutical Quality Assurance..by Manohar Potdar,Second edition Dec
2007,Nirali Prakashan.
3. IJRPC 2011 ‘An overview of pharmaceutical validation: quality
assurance view point’ by Nandhakumar et al.
4. TJPR Review Article ‘An Overview of Pharmaceutical Validation and
Process Controls in Drug Development’ Elsie Jatto and Augustine
O.Okhamafe
27